Covid 19 Clinical Trials

	Name (Synonyms)	Correlation
drug1086	Hydroxychloroquine Wiki	0.37
drug2840	hydroxychloroquine Wiki	0.25
drug1386	Low molecular weight heparin Wiki	0.24
drug2271	SivoMixx (200 billion) Wiki	0.24
drug670	Corticosteroid Wiki	0.24
drug1132	Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) Wiki	0.17
drug2661	Vitamin B12 Wiki	0.17
drug2786	consultation Wiki	0.17
drug2631	Vehicle Control Wiki	0.17
drug173	Angiotensin II Wiki	0.17
drug959	Folic Acid Wiki	0.17
drug1015	Group1 Wiki	0.17
drug749	Dexamethasone (high dose) Wiki	0.17
drug671	Corticosteroid injection Wiki	0.17
drug953	Flow cytometry Wiki	0.17
drug2101	Ritonavir Wiki	0.17
drug3043	ventilatory support with oxygen therapy Wiki	0.17
drug1391	Low-dose radiotherapy Wiki	0.17
drug783	Dociparastat sodium Wiki	0.17
drug1393	Lucinactant Wiki	0.17
drug2281	Sodium Nitrite Wiki	0.17
drug1839	Placebo capsules Wiki	0.17
drug1719	Oxygen supply Wiki	0.17
drug2535	Tocilizumab Injection [Actemra] Wiki	0.17
drug2717	Zinc Citrate Wiki	0.17
drug1229	Interleukin-1 receptor antagonist Wiki	0.17
drug2674	WFI 5% glucose Wiki	0.17
drug2586	Ultra-Low-dose radiotherapy Wiki	0.17
drug1256	Invasive mechanical ventilation Wiki	0.17
drug2103	Ritonavir/lopinavir Wiki	0.17
drug2202	Sars-Cov-2 serology Wiki	0.17
drug2637	Veru-111 Wiki	0.17
drug1720	Oxygen-ozone therapy, probiotic supplementation and Standard of care Wiki	0.17
drug1821	Piperacillin/tazobactam Wiki	0.17
drug74	APL-9 Wiki	0.17
drug1837	Placebo Tablet Wiki	0.17
drug1362	Lopinavir 200Mg/Ritonavir 50Mg Tab Wiki	0.17
drug352	Biological test Wiki	0.17
drug570	Cholecalciferol Wiki	0.17
drug2588	Umbilical Cord Mesenchymal Stem Cells Wiki	0.17
drug2702	XCEL-UMC-BETA Wiki	0.17
drug1354	Lopinavir Wiki	0.17
drug2693	Wharton's jelly derived Mesenchymal stem cells. Wiki	0.17
drug1356	Lopinavir / Ritonavir Pill Wiki	0.17
drug1935	Proxalutamide Wiki	0.17
drug73	AMY-101 Wiki	0.17
drug1024	HCQ & AZ Wiki	0.17
drug2719	Zinc Sulfate Wiki	0.17
drug1304	L-citrulline Wiki	0.17
drug799	Dutasteride Wiki	0.17
drug1176	Imaging by thoracic scanner Wiki	0.17
drug8	0.9% Sodium-chloride Wiki	0.17
drug1919	Prone Positioning (PP) Wiki	0.17
drug2194	Sampling of tissue Wiki	0.17
drug1103	Hydroxychloroquine Sulfate Wiki	0.14
drug1706	Oseltamivir Wiki	0.14
drug1270	Ivermectin Wiki	0.12
drug2422	TD-0903 Wiki	0.12
drug1642	Normal Saline Wiki	0.12
drug2357	Stellate Ganglion Block Wiki	0.12
drug2093	Rifampin Wiki	0.12
drug1047	Heparin Wiki	0.12
drug2467	Telmisartan Wiki	0.12
drug563	Chloroquine Sulfate Wiki	0.12
drug1365	Lopinavir-Ritonavir Wiki	0.12
drug2662	Vitamin C Wiki	0.10
drug1921	Prone position Wiki	0.10
drug1473	Mesenchymal Stromal Cells Wiki	0.10
drug2527	Tocilizumab Wiki	0.09
drug215	Ascorbic Acid Wiki	0.08
drug791	Doxycycline Wiki	0.08
drug2664	Vitamin D3 Wiki	0.08
drug2197	Sarilumab Wiki	0.08
drug2715	Zinc Wiki	0.07
drug2348	Standard treatment Wiki	0.07
drug2663	Vitamin D Wiki	0.06
drug1853	Placebo oral tablet Wiki	0.06
drug560	Chloroquine Wiki	0.06
drug1598	Nitazoxanide Wiki	0.06
drug1372	Lopinavir/ritonavir Wiki	0.05
drug1822	Placebo Wiki	0.05
drug658	Convalescent plasma Wiki	0.04
drug1860	Placebos Wiki	0.04
drug2326	Standard of care Wiki	0.04
drug1978	Questionnaire Wiki	0.04

Correlated MeSH Terms (23)

	Name (Synonyms)	Correlation
D055371	Acute Lung Injury NIH	0.32
D012128	Respiratory Distress Syndrome, Adult NIH	0.28
D012127	Respiratory Distress Syndrome, Newborn NIH	0.27
D013577	Syndrome NIH	0.19
D055370	Lung Injury NIH	0.18
D011470	Prostatic Hyperplasia NIH	0.17
D006965	Hyperplasia NIH	0.17
D003967	Diarrhea NIH	0.17
D000505	Alopecia NIH	0.12
D045888	Ganglion Cysts NIH	0.12
D045169	Severe Acute Respiratory Syndrome NIH	0.10
D011014	Pneumonia NIH	0.09
D018352	Coronavirus Infections NIH	0.08
D011024	Pneumonia, Viral NIH	0.06
D012598	Scoliosi NIH	0.06
D003141	Communicable Diseases NIH	0.06
D009103	Multiple Sclerosis NIH	0.06
D007239	Infection NIH	0.05
D018450	Disease Progression NIH	0.04
D014947	Wounds and Injuries NIH	0.04
D007249	Inflammation NIH	0.03
D016638	Critical Illness NIH	0.02
D014777	Virus Diseases NIH	0.02

Correlated HPO Terms (4)

	Name (Synonyms)	Correlation
HP:0008711	Benign prostatic hyperplasia HPO	0.17
HP:0002014	Diarrhea HPO	0.17
HP:0002293	Alopecia of scalp HPO	0.12
HP:0002090	Pneumonia HPO	0.09

There are 35 clinical trials

Clinical Trials

1 Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central nervous system (CNS). The etiology of MS is unknown, although the immune system appears to play a role. Many different infectious agents have been proposed as potential causes for MS, including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS of MS patients. These findings have been replicated in part by other laboratories. The purpose of the current study is to test whether antibiotic treatment aimed at eradicating Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these criteria will be randomized to either placebo or antibiotic therapy, and followed for 6 months on treatment.

NCT00043264 Multiple Sclerosis Drug: Rifampin Drug: Azithromycin

MeSH:Pneumonia Multiple Sclerosis Sclerosis

HPO:Pneumonia

2 Proactive Prophylaxis With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19

This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.

NCT04322396 Virus Diseases Infection Viral Corona Virus Infection Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo oral tablet Drug: Placebo oral tablet

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Severe Acute Respiratory Syndrome Virus Diseases

Primary Outcomes

Measure: Number of days alive and discharged from hospital within 14 days

Time: 14 days

Secondary Outcomes

Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".

Measure: Categorization of hospitalization status

Time: 14 days

Measure: Admitted to intensive care unit, if admitted to ICU then length of stay

Time: 14 days

Measure: Have used Non-invasive ventilation (NIV) during hospitalization

Time: 14 days

Measure: Mortality

Time: 30 days

Measure: Length of hospitalization

Time: 14 days

Measure: Days alive and discharged from hospital

Time: 30 days

Measure: Mortality

Time: 90 days

Measure: Mortality

Time: 365 days

Measure: Number of readmissions (all causes)

Time: 30 days

Measure: Number of days using non-invasive ventilation (NIV)

Time: 14 days

Description: Delta PaO2 measured in arterial puncture

Measure: Change in patient's oxygen partial pressure

Time: 4 days

Description: Delta PaCO2 measured in arterial puncture

Measure: Change in patient's carbondioxid partial pressure

Time: 4 days

Description: pH measured in arterial puncture

Measure: Level of pH in blood

Time: 4 days

Measure: Time for no oxygen supplement (or regular oxygen supplement "LTOT")

Time: 14 days

3 Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial

This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19.

NCT04329832 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Description: Per https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, this scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".

Measure: COVID Ordinal Outcomes Scale at 14 days

Time: Assessed once on day 14 after enrollment (enrollment is day 0)

Secondary Outcomes

Description: Calculated as a worst-rank ordinal (death is counted as -1 days).

Measure: Hospital-free days at 28 days (number of days patient not in hospital)

Time: Admission (day 1) to 28 days after admission (day 28)

Description: Calculated as a worst-rank ordinal (death is counted as -1 days).

Measure: Ventilator-free days at 28 days (number of days patient not on a ventilator)

Time: Admission (day 1) to 28 days after admission (day 28)

Description: Calculated as a worst-rank ordinal (death is counted as -1 days).

Measure: ICU-free days at 28 days (number of days patient not in an ICU)

Time: Admission (day 1) to 28 days after admission (day 28)

Measure: Time to a 1-point decrease in the WHO ordinal recovery score

Time: Admission (day 1) to 14 days after admission (day 14)

4 Pilot, Randomized, Multicenter, Open-label Clinical Trial of Combined Use of Hydroxychloroquine, Azithromycin, and Tocilizumab for the Treatment of SARS-CoV-2 Infection (COVID-19)

COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality. Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.

NCT04332094 COVID-19 Drug: Tocilizumab Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Measure: In-hospital mortality

Time: Through hospitalization, an average of 2 weeks

Measure: Need for mechanical ventilation in the Intensive Care Unit

Time: Through hospitalization, an average of 2 weeks

5 Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19

This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.

NCT04332107 COVID-19 SARS-CoV-2 Drug: Azithromycin Drug: Placebos

Primary Outcomes

Description: All-cause hospitalization or emergency room stay of >24 hours

Measure: Hospitalization

Time: 14 days

Secondary Outcomes

Description: Viral load by self-collected nasal swab

Measure: Viral load

Time: 3 days

Description: Viral load by self-collected saliva swab

Measure: Viral load

Time: 3 days

Description: All-cause mortality

Measure: Mortality

Time: 14 days

Description: Proportion of participants experiencing adverse events, including gastrointestinal side effects and rash

Measure: Adverse events

Time: 3 days

Description: Prevalence of positive SARS-CoV-2 test by self-collected nasal swab

Measure: Positive SARS-CoV-2 test - nasal swab

Time: 3 days

Description: Prevalence of positive SARS-CoV-2 test by self-collected saliva swab

Measure: Positive SARS-CoV-2 test - saliva swab

Time: 3 days

Description: Prevalence of positive SARS-CoV-2 test by self-collected rectal swab

Measure: Positive SARS-CoV-2 test - rectal swab

Time: 3 days

Description: Prevalence of genetic macrolide resistance determinants by self-collected rectal swab

Measure: Genetic macrolide resistance determinants

Time: 3 days

Description: Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms

Measure: COVID-19 symptoms

Time: 3, 7, 14, 21 days

Description: Number of emergency room visits <24 hours

Measure: Number of emergency room visits

Time: 14 days

Description: Number of household members with confirmed or symptomatic COVID-19

Measure: Number of household members with COVID-19 (confirmed or symptomatic)

Time: 14 days

Description: Deaths within the study will be attempted to be matched with the US National Death Index

Measure: Death

Time: 21 days

6 Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial

This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.

NCT04334382 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Description: Admitted to a hospital (not merely kept for emergency room observation)

Measure: Hospitalization within 14 days of enrollment

Time: From enrollment to 14 days after enrollment

Secondary Outcomes

Measure: Duration of COVID-19-attributable symptoms

Time: From enrollment to 14 days after enrollment

Description: Hospital-free days at 28 days (number of days patient not in hospital); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score

Measure: Hospital-free days at 28 days

Time: Admission (day 1) to 28 days after admission (day 28)

Description: Ventilator-free days at 28 days (number of days patient not on a ventilator); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score

Measure: Ventilator-free days at 28 days

Time: Admission (day 1) to 28 days after admission (day 28)

Description: ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score

Measure: ICU-free days at 28 days

Time: Admission (day 1) to 28 days after admission (day 28)

7 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).

NCT04334512 COVID-19 Corona Virus Infection Coronavirus-19 Sars-CoV2 Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR

Measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy

Time: 12 weeks

Description: Reduction and/or progression of symptomatic days, reduction of symptom severity

Measure: Reduction or Progression of Symptomatic Days

Time: 12 weeks

Description: Assess the symptom response to study therapy as measured by the survey in the EDC

Measure: Assess the safety of Quintuple Therapy

Time: 12 weeks

Description: Pulse from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via pulse

Time: 12 weeks

Description: Oxygen saturation from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via oxygen saturation

Time: 12 weeks

Description: EKG response from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via EKG

Time: 12 weeks

Description: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy

Measure: Assess Tolerability of Quintuple Therapy

Time: 12 weeks

8 Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin

NCT04335552 SARS-CoV-2 Other: Standard of care Drug: Hydroxychloroquine Drug: Azithromycin

MeSH:Infection

Primary Outcomes

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: World Health Organization (WHO) ordinal scale measured at 14 days after enrollment

Time: Day 14

Secondary Outcomes

Measure: Rates of death during the index hospitalization

Time: Index hospitalization, up to 46 days

Measure: Number of days on mechanical ventilation for patients who were on mechanical ventilation at baseline

Time: Baseline

Measure: Proportion of patients not receiving mechanical ventilation at baseline who progress to requiring mechanical ventilation during the index hospitalization

Time: Index hospitalization, up to 46 days

Measure: WHO ordinal scale measured at 28 days after enrollment

Time: Day 28

Measure: Hospital length of stay in days for the index hospitalization

Time: Index hospitalization, up to 46 days

Measure: Rates of all-cause study medication discontinuation

Time: Index hospitalization, up to 46 days

Measure: Rates of severe adverse events

Time: Day 14

9 Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment

To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).

NCT04338698 COVID 19 Drug: Hydroxychloroquine Drug: Oseltamivir Drug: Azithromycin

Primary Outcomes

Description: The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of < 150 i.u

Measure: Laboratory Result

Time: Day 07 on follow-up

Description: The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below: Not hospitalized, able to resume normal activities Not hospitalized, but unable to resume normal activities Hospitalization, not requiring supplemental oxygen Hospitalization, requiring supplemental oxygen Hospitalization, requiring noninvasive mechanical ventilation Hospitalization, requiring invasive mechanical ventilation Death

Measure: Clinical Outcome

Time: Day 07 on follow-up

10 Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care Due to Coronavirus Disease 2019 (COVID-19)- Randomised Controlled Trial

Trial design: Prospective, multi-centre, randomised, pragmatic, double blind trial Methods: Participants: Adult (>18 years) within 24 hours of admission to intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria: symptoms of febrile disease for ≥1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, incl. long QT syndromes, participation in another outcome-based interventional trial within last 30 days, patients taking Hydrochloroquine for other indication than COVID-19, pregnancy. Interventions: Patients will be randomised in 1:1:1 ratio to receive Hydrochloroquine 800mg orally in two doses followed by 400mg daily in two doses and Azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or Hydrochloroquine+ placebo (HC group) or placebo + placebo (C-group) in addition to best standard of care, which may evolve during the trial period but will not differ between groups. Objective: To test the hypothesis that early administration of combination therapy slows disease progression and improves mechanical-ventilation free survival. Outcomes: Primary outcome: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14. Secondary outcomes: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline. ICU-LOS D28 and D 90 mortality (in hospital) Tertiary (exploratory) outcomes: Viral load at D7 of study enrolment (No of viral RNA copies/ml of blood), proportion of patients alive and rtPCR negative from nasal swab at D14, Difference of FiO2 requirement and respiratory system compliance between day 0 and 7. Randomization: In 1:1:1 ratio and stratified according to study centre and patients age (cut-off 70 years) Blinding (masking): Patients, treating clinicians, outcome assessors and data analyst will be blinded to study treatment allocation. Unblinded study pharmacist or research nurse will prepare investigational products.

NCT04339816 COVID-19 Respiratory Failure Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo

MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14.

Measure: Proportion of alive patients free off mechanical ventilation

Time: 14 days after enrolment

Secondary Outcomes

Description: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline.

Measure: Proportion of patients who avoided the need of mechanical ventilation

Time: 14 days

Description: Length of stay in intensive care unit

Measure: ICU LOS

Time: 28 days

Description: Proportion of patients who died by day 28

Measure: Mortality28

Time: 28 days

Description: Proportion of patients who died by day 90

Measure: Mortality90

Time: 90 days

11 COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients

To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A). To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).

NCT04341207 Cancer Cancer & Cancer & COVID 19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Measure: Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients

Time: Up to 3 months

Measure: Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin

Time: Up to 12 months

12 WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection

This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

NCT04341727 Coronavirus Infection Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Chloroquine Sulfate

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death

Measure: Hours to recovery

Time: 42 days

Secondary Outcomes

Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications

Measure: Time fever resolution

Time: 42 days

13 Efficacy of Sarilumab + Azithromycin + Hydroxychloroquine, and Sarilumab Alone, for Adult Patients Hospitalized With Moderate to Severe COVID-19: a Multicenter Open-label 1:1 Randomized Controlled Trial

The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with moderate, severe pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering investigational treatments administration to patients enrolled in the CORIMUNO-19 cohort (NCT04324047). Sarilumab+Azithromycin+Hydroxychloroquine, or Sarilumab only will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation. All patients will receive standard of care along with randomized investigational treatments. Outcomes of included patients will be compared between groups as well as with outcomes of patients in the CORIMUNO-19 cohort treated with other immune modulators or standard of care.

NCT04341870 COVID19 SARS-CoV-2 Infection Drug: Sarilumab Drug: Azithromycin Drug: Hydroxychloroquine

Primary Outcomes

Description: Events considered are: need for ventilation (including invasive and non invasive ventilation), transfer to the Intensive Care Unit, death or new do-not-resuscitate (DNR) decision in the absence ventilation and outside ICU.

Measure: Need for ventilation (including invasive and non invasive ventilation), intensive care or death

Time: 14 days

Secondary Outcomes

Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: Early improvement: OMS progression scale <= 5

Time: 4 days

Measure: OMS progression scale

Time: 4, 7 and 14 days

Description: Overall survival

Measure: Survival

Time: 14, 28 and 90 days

Description: Number of ICU-free days alive

Measure: ICU-free days alive

Time: 14, 28 and 90 days

Description: Number of ventilation(invasive or non invasive)-free days alive

Measure: Ventilation-free days alive

Time: 14 and 28 days

Description: Number of hospital-free days alive

Measure: Hospital-free days alive

Time: 14, 28 and 90 days

Description: Number of oxygen therapy-free days alive

Measure: Oxygen therapy-free days alive

Time: 14 and 28 days

Description: SARS-CoV-2 viral load measurement by rtPCR

Measure: Time to negative viral excretion

Time: 90 days

Description: Immunophenotyping and multiplex cytokines (blood sample)

Measure: Immunophenotyping and multiplex cytokines

Time: 8 days

14 Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial

This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.

NCT04344444 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Description: ordinal outcome of most severe a patient experienced after inpatient admission

Measure: Most severe outcome

Time: 5 days

15 Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.

NCT04349592 Covid19 Drug: Hydroxychloroquine Drug: Azithromycin Other: Placebo Tablet Other: Placebo capsules

Primary Outcomes

Description: Days

Measure: Proportion of virologically cured (PCR-negative status) as assessed on day six

Time: Day 6

Secondary Outcomes

Description: Days

Measure: virologic cure on other study days

Time: Day14 and Day 21

Description: Days

Measure: virologic semiquantitative analysis of changing viral load

Time: Day 1 to Day 21

Description: Days

Measure: proportion of initially symtomatic subjects with disappearance of clinical symptoms

Time: Day14 and Day 21

Description: Days

Measure: proportion of initially asymtomatic subjects with appearance of new clinical symptoms

Time: Day14 and Day 21

Description: grades

Measure: proportions of subjects with potentially medication- related adverse events

Time: 7 day

16 Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial

This is a randomized trial for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in high-risk adults not requiring hospital admission.The overarching goal of this study is to assess the effectiveness of interventions on the incidence of lower respiratory tract infection (LRTI) progression among high-risk adult outpatients with SARS-CoV-2 infection to inform public health control strategies.

NCT04354428 COVID-19 SARS-CoV-2 Drug: Ascorbic Acid Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Folic Acid

Primary Outcomes

Description: Resting blood oxygen saturation (SpO2<93%) level sustained for 2 readings 2 hours apart and presence of subjective dyspnea or cough

Measure: Lower respiratory tract infection (LRTI) rates

Time: 28 days from enrolment

Description: Cumulative incidence of hospitalization or mortality

Measure: Incidence of hospitalization or mortality

Time: Day 28 after enrolment

Description: Time to clearance of nasal SARS-CoV-2, defined as 2 consecutive negative swabs

Measure: Change in upper respiratory viral shedding

Time: Day 1 through Day 14 after enrolment

Secondary Outcomes

Description: Serious adverse events (including death and hospitalization) and adverse events resulting in treatment discontinuation

Measure: Rate of participant-reported adverse events

Time: 28 days from enrolment

17 Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia: A Pragmatic Randomized Controlled Trial

Introduction: The COVID-19 pandemic is characterized by significant morbidity and mortality. It is caused by a novel coronavirus with no current specific prevention nor treatment therapies. Treatments have been administered to patients with COVID-19 in order to control viral infection, among them: Chloroquine (CQ) and Hydroxychloroquine (HCQ), Lopinavir/Ritonavir (Lop/r), Remdesivir, Favipavir, acting over bacterial co-infection Azithromycin (Azithro), or modifying the inflammatory response of the host (Tocilizumab). Clinical trials offer conflicting evidence regarding the effectiveness and safety of therapies The real effectiveness and safety profile of the treatments for COVID-19 remains unknown. Objective: Evaluate the effectiveness and safety of pharmacological therapies used to treat adult patients with COVID-19. Methods: Pragmatic randomized controlled trial. Study population: Adults aged 18 years or over with a positive real-time polymerase chain reaction (RT-PCR) for Severe Acute Respiratory Syndrome CoV-2 (SARS CoV-2) and diagnosis of mild, severe or critical pneumonia, requiring hospital management at six hospitals in Colombia. Exclusion criteria: Pregnancy, known allergy to treatment, cirrhosis or hepatic abnormality (transaminases greater than 5 reference values), prolonged QT interval, glomerular filtration rate lesser than 30 ml/min/1.73m^2, history of lung fibrosis, advanced or metastatic cancer. Sample size: 1,600 participants. The study will be carried out in two phases. The first phase will be conducted with 480 participants and aims to identify treatments with higher or minimum potential, discontinue treatments with higher toxicity and have opportunity of introducing new treatments with potential efficacy. The second phase will be conducted with 1,120 participants to evaluate the effectiveness of the selected treatments. Four interventions have been defined: I1 HCQ, I2 HCQ plus Lop/r, I3 HCQ plus Azithro and I4 standard treatment. Within each institution, participants will be randomly assigned to one of the treatment arms assigned to that institution. Concealment will be kept through a central telephone. Treatment administration will be open. Variables: Sociodemographic and clinical at recruitment; (comorbidities, need for therapeutic support , grade of invasion at admission). Primary outcomes. Effectiveness: Mortality. Safety: Serious adverse events (AE) assessed by the NCI Community Oncology Research Program (NCORP) Guidance for Collection of Adverse Events Related to COVID-19 Infection. Secondary outcomes: Intensive care unit (ICU) admission, requirement of respiratory support, time to death, number of participants cured, any adverse event related to treatment. Analysis: Descriptive for the presentation of summary measures of the basal conditions by type of variable. Bivariate. Description of the basal conditions (with organic failure at admission, without failure at admission), by type of treatment, by participating institution. Description of crude effectiveness and safety by means of the difference of accumulated incidences, each one with 95% confidence intervals (95% CI) Intention to treat analyisis will be done. Adjusted analysis: The ratio and difference of cumulative incidences of mortality at 7 and 28 days and severe adverse events between treatments will be estimated, adjusting for confounding variables using logistic regression models with mixed effects considering each institution as a level or from equations. generalized estimation (GEE). Ethical considerations: The study has a risk beyond minimum according to the Resolution 8430/1993 of the Colombian Ministry of Health. Informed consent will be explained and signed if the patient is in condition to do so. This protocol will undergo evaluation by the ethics committee at each of the participating institutions and at the National University of Colombia. The protocol follows the Helsinki Declaration and institutional protocols for clinical investigation.

NCT04359095 COVID-19 Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Pill Drug: Azithromycin Other: Standard treatment

Primary Outcomes

Description: Cumulative incidence

Measure: Mortality

Time: Post-intervention at day 28

Description: Number of participants that develop severe adverse events related to the treatment

Measure: Number of Participants with Treatment Related Severe Adverse Events as Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection

Time: Post-intervention at day 28

Secondary Outcomes

Description: Cumulative incidence

Measure: Mortality

Time: Post-intervention at day 7

Description: Number of participants that develop severe adverse events related to the treatment

Measure: Number of Participants with Treatment Related Severe Adverse Events as Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection

Time: Post-intervention at day 7

Description: Time from the date of assignment until the date of death from any cause

Measure: Time to death

Time: Assessed up to 28 days postintervention

Description: Number of Participants that require management in the ICU

Measure: Number of Participants that are transferred to the Intensive Care Unit (ICU)

Time: Post-intervention at day 28

Description: Participants requiring invasive mechanical ventilation

Measure: Number of Participants that need Mechanical Ventilation Support with endotracheal intubation.

Time: Up to 28 days after hospital admission

Description: Number of participants cured assessed RT-PCR for SARS CoV-2, without clinical symptoms and no radiological signs assessed by chest X ray

Measure: Number of participants Cured assessed by Nasopharyngeal swab, oropharyngeal swab, and blood aspiration for COVID19 (RT-PCR) without clinical symptoms and normal chest X ray

Time: Up to 28 days after hospital admission

Description: Any adverse event

Measure: Number of Participants with Any Adverse Event Related to Treatment Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection

Time: Up to 28 days after hospital admission

Other Outcomes

Description: Interim assessment of safety, which will be conducted after 480 participants are recruited. It will be evaluated through absolute frequency of severe AE and relative frequency measurements (proportion of total number of participants with severe adverse events divided by the total number of participants treated). It aims to aid the decision of excluding an active treatment arm should that arm have more than 3 serious adverse events in the first 30 participants or a serious adverse events incidence of 10 percent or higher.

Measure: Severe Adverse events

Time: Up to 28 days after hospital admission

Description: Interim assessment of minimum effectiveness, which will be conducted after 480 participants are recruited. It will be evaluated through relative frequency measurements (mortality proportion at 28 days of treatment). It aims to aid the decision of excluding an active treatment arm should that treatment arm have an efficacy lower than 0.2, calculated through futility analysis that assumes an expected difference of 10 percent at the end of the first phase of the study. For all the tests carried out in the interim analysis, the correction of the type I error will be made using the O'Brien-Fleming method.

Measure: Mortality

Time: Up to 28 days after hospital admission

18 Efficacy and Safety of Azithromycin Compared to the Base Therapeutic Regiment of Hydroxychloroquine in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial

The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

NCT04359316 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Description: Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.

Measure: Time to clinical improvement

Time: From date of randomization until 14 days later.

Secondary Outcomes

Description: If the patient dies, we have reached an outcome.

Measure: Mortality

Time: From date of randomization until 14 days later.

Description: Pulse-oxymetry

Measure: SpO2 Improvement

Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.

Description: Incidence of new mechanical ventilation use (Rate)

Measure: Incidence of new mechanical ventilation use

Time: From date of randomization until 14 days later.

Description: Duration of hospitalization (Days)

Measure: Duration of hospitalization

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.

Description: With incidence of any serious adverse effects, the outcome has happened.

Measure: Cumulative incidence of serious adverse events

Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.

19 Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19: a Randomized, Multicenter, Adaptative Study

In November 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients who died most often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%). These elderly patients with COVID19 are therefore very fragile and require treatment that fights the virus but is also adapted to their state of health and age. Most of current therapeutic trials worldwide exclude people aged over 75 years, which is precisely the age group affected by COVID19. We therefore propose to carry out a therapeutic trial specific to the elderly with drugs at doses that are bearable for these patients. Using the WHO, clinicaltrial, pubmed and the Chinese CCDC/CHCTR websites to find the better drugs adapted to elderly people, we decided after concertation between infectiologists and geriatricians to do a four arms clinical trial during two weeks twice a day: Hydroxychloroquine 200mg, Telmisartan 40mg, Azithromycin 250mg and standard care. We therefore hypothesize that one or more of these treatments may have a beneficial effect in controlling COVID19, without major and repeated side effects in elderly patients.

NCT04359953 COVID-19 Infection Drug: Hydroxychloroquine Drug: Azithromycin Drug: Telmisartan

Primary Outcomes

Measure: Two-weeks survival rate

Time: Day 14

Secondary Outcomes

Measure: Rate of undetectable RT-PCR of SARS-CoV-2

Time: Day 7

Measure: Rate of undetectable RT-PCR of SARS-CoV-2

Time: Day 14

Measure: Rate of death

Time: Day 28

Measure: Hypotension

Time: Day 7

Measure: Hypotension

Time: Day 14

Measure: Hypothermia and hyperthermia

Time: Day 7

Measure: Hypothermia and hyperthermia

Time: Day 14

Measure: Pneumonia severity according to WHO

Time: Day 7

Measure: Pneumonia severity according to PSI (Hung et al 2017)

Time: Day 7

Measure: Pneumonia severity according to WHO

Time: Day 14

Measure: Pneumonia severity according to PSI (Hung et al 2017)

Time: Day 14

Measure: Rate of no cough

Time: Day 7

Measure: Rate of no cough

Time: Day 14

Measure: Rate of no dyspnea

Time: Day 7

Measure: Rate of no dyspnea

Time: Day 14

Measure: Rate of no fever

Time: Day 7

Measure: Rate of no fever

Time: Day 14

Measure: Rate of no requiring supplemental oxygen

Time: Day 7

Measure: Rate of no requiring supplemental oxygen

Time: Day 14

Measure: Rate of SARS-Cov-2 undetectable

Time: Day 7

Measure: Rate of SARS-Cov-2 undetectable

Time: Day 14

Measure: Recovery time

Time: Day 28

Measure: Critical admission rate

Time: Day 28

Measure: Mechanical ventilation rate

Time: Day 28

Measure: Changes in Activity of Daily Living (ADL) Activity of Daily Living)

Time: Day 13

Measure: Changes in Activity of Daily Living IADL (Instrumental Activity of Daily Living)

Time: Day 13

Measure: The number and dose of added corticosteroids, immonumodulators or immunosuppressants

Time: Day 14

20 VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)

We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.

NCT04363203 SARS-CoV-2 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Drug: Placebo oral tablet

Primary Outcomes

Measure: Days to resolution of cough, fever and shortness of breath

Time: 30-days

Secondary Outcomes

Measure: Days to resolution of all COVID-19 symptoms

Time: 30-days

Measure: All cause hospitalization

Time: 30-days

Measure: All cause mortality

Time: 30-days

Measure: COVID-19 specific mortality

Time: 30-days

Measure: COVID-19 specific hospitalization

Time: 30-days

21 A Randomized Trial of Efficacy and Safety of an Early OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome: a Strategy to Prevent Hospitalization

COVID-19 is a respiratory disease due to a novel coronavirus (SARS-CoV-2) that causes substantial morbidity and mortality. To date, no treatment has been proved to be effective in COVID-19. Elderly patients and patients with comorbidities have the worse prognosis with a higher risk of hospitalization, ICU admission and death. The efficacy of an early outpatient treatment could be suggested but need to be confirmed. This confirmation is mandatory to improve prognosis of COVID-19 but also to avoid unsuspected deleterious effect of drugs already used in clinical practice but not based on evidence.

NCT04365582 COVID Drug: Azithromycin Drug: Hydroxychloroquine Drug: Lopinavir 200Mg/Ritonavir 50Mg Tab

Primary Outcomes

Description: Hospitalization at D20

Measure: Hospital admission

Time: Day 20

Secondary Outcomes

Description: This outcome corresponds to the number of patients who died on day 20.

Measure: Effect of treatment on Death at D20

Time: Day 20

Description: This outcome corresponds to the number of patients who died on day 60.

Measure: Effect of treatment on Death at D60

Time: Day 60

Description: This outcome corresponds to the number of patients who died due to COVID on day 20.

Measure: Effect of treatment on Death due to COVID at D20

Time: Day 20

Description: This outcome corresponds to the number of patients who died due to COVID on day 60.

Measure: Effect of treatment on Death due to COVID at D60

Time: Day 60

Description: This outcome corresponds to the number of participants who need ICU stay at day 20.

Measure: Effect of treatment on need for ICU stay at D20

Time: Day 20

Description: This outcome corresponds to the number of participants who need ICU stay at day 60.

Measure: Effect of treatment on need for ICU stay at D60

Time: Day 60

Description: This outcome evaluates the duration of patient's ICU stay at day 20.

Measure: Effect of treatment on duration of ICU stay at D20

Time: Day 20

Description: This outcome evaluates the duration of patient's ICU stay at day 60.

Measure: Effect of treatment on duration of ICU stay at D60

Time: Day 60

Description: This outcome corresponds to the number of participants who need mechanical ventilation at D20.

Measure: Effect of treatment on need of mechanical ventilation at D20

Time: Day 20

Description: This outcome corresponds to the number of participants who need mechanical ventilation at D60.

Measure: Effect of treatment on need of mechanical ventilation at D60

Time: Day 60

Description: This outcome corresponds to the duration of patient's mechanical ventilation at D20.

Measure: Effect of treatment on duration of mechanical ventilation at D20

Time: Day 20

Description: This outcome corresponds to the duration of patient's mechanical ventilation at D60.

Measure: Effect of treatment on duration of mechanical ventilation at D60

Time: Day 60

Description: This outcome evaluates the delay between inclusion and hospitalization at D20.

Measure: Effect of treatment on time to hospitalization at D20

Time: Day 20

Description: This outcome evaluates the delay between inclusion and hospitalization at D60.

Measure: Effect of treatment on time to hospitalization at D60

Time: Day 60

Description: This outcome evaluates the duration of patient's Hospital stay at D20.

Measure: Effect of treatment on Duration of Hospital stay et D20

Time: Day 20

Description: This outcome evaluates the duration of patient's Hospital stay at D60.

Measure: Effect of treatment on Duration of Hospital stay et D60

Time: Day 60

Description: This outcome evaluates the duration of symptoms at D20 after treatment.

Measure: Effect of treatment on Duration of symptoms at D20

Time: Day 20

Description: This outcome evaluates the duration of symptoms at D60 after treatment.

Measure: Effect of treatment on Duration of symptoms at D60

Time: Day 60

Description: This outcome measures the number of participants with treatment-related adverse events as assessed by CTCAE v4.0, at the end of study.

Measure: Incidence of Treatment-Emergent Adverse Events

Time: Month 6

Other Outcomes

Description: This outcome evaluates the chest radiological features on Chest HRCT, at 6 months, after treatment.

Measure: Effect of treatment on chest radiological features

Time: Month 6

Description: This outcome evaluates the Pulmonary function test at 6 month, after treatment.

Measure: Effect of treatment on respiratory capacity

Time: Month 6

Description: This ouctome eavaluates costs and consequences which will be presented for each stakeholder in a disaggregated way at the end of study.

Measure: Cost consequence analysis

Time: Month 6

22 Oxygen-Ozone as Adjuvant Treatment in Early Control of Disease Progression in Patients With COVID-19 Associated With Modulation of the Gut Microbial Flora

Italy was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidity and mortality associated with the disease. In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease 19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an interventional, non-pharmacological, open, randomized, prospective, non-profit study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early control of disease progression in patients with COVID-19. Contextually, all patients are treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based intervention (accompanied by supplementation with probiotics) in containing the progression of COVID-19 and in preventing the need for hospitalization in intensive care units.

NCT04366089 COVID SARS-CoV 2 Pneumonia, Viral Coronavirus Infection Other: Oxygen-ozone therapy, probiotic supplementation and Standard of care Dietary Supplement: SivoMixx (200 billion) Drug: Azithromycin Drug: hydroxychloroquine

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Comparison between the two groups

Measure: Delta in the number of patients requiring orotracheal intubation despite treatment

Time: 21 days

Secondary Outcomes

Description: Comparison between the two groups

Measure: Delta of crude mortality

Time: 21 days

Description: Comparison between the two groups

Measure: Delta of length of stay for patients in hospital

Time: 90 days

Description: Comparison between the two groups

Measure: delta in the value of interleukin (IL)-1

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-6

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-10

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of Tumor Necrosis Factor (TNF)-alpha

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of cluster of differentiation (CD)4+ CD38/ Human Leukocyte Antigen-DR isotype (HLA-DR)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of CD8+ CD38/ HLA-DR

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of fecal calprotectin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of lipopolysaccharide (LPS)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of zonulin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of alpha1-antitrypsin

Time: 21 days

23 Evaluation of the Impact of Bacteriotherapy in the Treatment of COVID-19

In light of its high morbidity and mortality, COronaVIrus Disease 19 (COVID-19) pandemic spread is considered an unprecedented global health challenge. Given the very limited therapeutic options available against Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic at this time, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an observational, retrospective, non-profit study on the adjuvant use of bacteriotherapy in the early control of disease progression in patients affected by COVID-19 and treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of bacteriotherapy in reducing the clinical impact of acute diarrhea, containing the progression of COVID-19 and preventing the need for hospitalization in intensive care units.

NCT04368351 COVID Pneumonia Diarrhea Dietary Supplement: SivoMixx (200 billion) Drug: Azithromycin Drug: hydroxychloroquine

MeSH:Pneumonia Diarrhea

HPO:Diarrhea Pneumonia

Primary Outcomes

Description: Comparison between the two groups. Acute diarrhea was defined as a stool with increased water content, volume, or frequency that lasts less than 14 days.

Measure: delta of time of disappearance of acute diarrhea

Time: 21 days

Secondary Outcomes

Description: Comparison between the two groups

Measure: Delta in the number of patients requiring orotracheal intubation despite treatment

Time: 21 days

Description: Comparison between the two groups

Measure: Delta of crude mortality

Time: 21 days

Description: Comparison between the two groups

Measure: Delta of length of stay for patients in hospital

Time: 21 days

24 A Randomized Study Evaluating the Safety and Efficacy of Hydroxychloroquine and Zinc in Combination With Either Azithromycin or Doxycycline for the Treatment of COVID-19 in the Outpatient Setting

This is a randomized, open-label trial to assess the safety and efficacy of hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a higher risk COVID-19 positive outpatient population.

NCT04370782 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Drug: Zinc Sulfate Drug: Doxycycline

Primary Outcomes

Description: Patients will be assessed on day 5 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)

Measure: Time to Resolution of Symptoms relative to baseline (day 1 of trial)

Time: Day 5

Description: Patients will be assessed on day 14 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)

Measure: Time to Resolution of Symptoms relative to baseline (day 1 of trial)

Time: Day 14

Description: Patients will be assessed on day 21 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)

Measure: Time to Resolution of Symptoms relative to baseline (day 1 of trial)

Time: Day 21

Description: Number of participants hospitalized and/or requiring repeat ER visits related to COVID-19 complications

Measure: Number of participants hospitalized and/or requiring repeat ER visits

Time: 21 days

Description: If hospitalized, number of participants admitted to the ICU, and number of days in the ICU

Measure: ICU Length of Stay

Time: Until Discharged up to 30 days

Description: If placed on ventilator, number of days on a ventilator

Measure: Ventilator

Time: Until extubated up to 30 days

Secondary Outcomes

Description: Severity of symptoms evaluated at day 5, day 14, and day 21 scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)

Measure: Severity of symptoms

Time: Day 5, Day 14, and Day 21

Description: Number of participants with adverse events due to drug regimen

Measure: Number of participants with adverse events due to drug regimen

Time: 21 days

Description: Assess all patients to evaluate for QTc prolongation >500ms

Measure: Number of participants with QTc prolongation >500ms

Time: Days 1 thru 5, Day 10, Day 21

25 Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial

On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world. To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted. It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Therefore azithromycin (AZM) is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases). The aim of this study is to demonstrate that AZM decreases symptom duration in COVID19 patients and diminishes the viral carriage.

NCT04371107 Covid19 Azithromycin Ambulatory Other: consultation Drug: Azithromycin

Primary Outcomes

Description: Length of symptom duration (in days) with azithromycin treatment

Measure: Length of symptom duration (in days) with azithromycin treatment

Time: up to 2 months

26 Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study

Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients. Main objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.

NCT04380818 Pneumonia, Viral Radiation: Low-dose radiotherapy Drug: Hydroxychloroquine Sulfate Drug: Ritonavir/lopinavir Drug: Tocilizumab Injection [Actemra] Drug: Azithromycin Drug: Corticosteroid Drug: Low molecular weight heparin Device: Oxygen supply

MeSH:Pneumonia, Viral Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: To evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to baseline pre-irradiation measurement. . In cases of impossibility the SaFiO2 will be determined

Measure: Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%

Time: Day 2 after interventional radiotherapy

Secondary Outcomes

Description: Lung toxicity measured according to CTCAEv5

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time: Day 30 and day 90 after interventional radiotherapy

Description: Chest CT

Measure: Change of the radiological image

Time: Days 7 and day 30 after interventional radiotherapy

Description: Death of any cause

Measure: Overall mortality

Time: Day 15 and Day 30 after interventional radiotherapy

Description: Interleukins IL-6, IL-10, IL-1, IL-2, IL-8 (pg/ml)

Measure: Measure of pro-inflammatory interleukins

Time: Days 1, day 4 and day 7 after interventional radiotherapy

Description: TGF-β (ng/ml)

Measure: Measure of trasforming growth factor (TGF-b)

Time: Days 1, day 4 and day 7 after interventional radiotherapy

Description: TNF-α (pg/ml)

Measure: Measure of tumor necrosis factor alpha (TNF-a)

Time: Days 1, day 4 and day 7 after interventional radiotherapy

Description: Overexpression of L-, E-, and P-selectin

Measure: Determining overexpression of pro-inflammatory selectin

Time: Days 1, day 4 and day 7 after interventional radiotherapy

Description: Overexpression of ICAM-1, VCAM

Measure: Determining cell adhesion molecules (CAMs)

Time: Days 1, day 4 and day 7 after interventional radiotherapy

Description: PON-1(paraoxonase and arylesterase activity) (IU/ml)

Measure: Measure of marker of oxidative stress PON-1

Time: Days 1, day 4 and day 7 after interventional radiotherapy

27 Randomised Evaluation of COVID-19 Therapy

RECOVERY is a randomised trial investigating whether treatment with either Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Convalescent plasma or Tocilizumab prevents death in patients with COVID-19.

NCT04381936 Severe Acute Respiratory Synd Severe Acute Respiratory Syndrome Drug: Lopinavir-Ritonavir Drug: Corticosteroid Drug: Hydroxychloroquine Drug: Azithromycin Biological: Convalescent plasma Drug: Tocilizumab

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality.

Measure: All-cause mortality

Time: Within 28 days after randomisation

Secondary Outcomes

Description: To assess the effects of study treatment on number of days stay in hospital

Measure: Duration of hospital stay

Time: Within 28 days and up to 6 months after the main randomisation

Description: Among patients not on mechanical ventilation at baseline, the number of patients with a composite endpoint of death or need for mechanical ventilation or ECMO.

Measure: Composite endpoint of death or need for mechanical ventilation or ECMO

Time: Within 28 days and up to 6 months after the main randomisation

Other Outcomes

Description: To assess the effects of study treatment on number of patients who needed ventilation and the number of days it was required

Measure: Need for (and duration of) ventilation

Time: Within 28 days and up to 6 months after the main randomisation

Description: To assess the effects of study treatment on number of patients who needed renal replacement therapy

Measure: Need for renal replacement

Time: Within 28 days and up to 6 months after the main randomisation

Description: To assess the effects of study treatment on number of patients who develop new major cardiac arrythmias

Measure: Development of new major cardiac arrythmias

Time: Within 28 days and up to 6 months after the main randomisation

28 Novel Treatment Regimens in Treatment of COVID-19

Azithromycin has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.

NCT04382846 COVID Corona Virus Infection Drug: Nitazoxanide Drug: Ivermectin Drug: Chloroquine Drug: Azithromycin

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: the number of patients with virological cure

Measure: Number of patients with virological cure

Time: 6 months

29 Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers

The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose < 1 Gy. The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.

NCT04394182 Pneumonia, Viral Cytokine Storm Radiation: Ultra-Low-dose radiotherapy Device: ventilatory support with oxygen therapy Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine Drug: Azithromycin Drug: Piperacillin/tazobactam Drug: Low molecular weight heparin Drug: Corticosteroid injection Drug: Tocilizumab

MeSH:Pneumonia, Viral Pneu Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 2

Time: At 2 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2

Time: At 2 days after RT

Secondary Outcomes

Description: Pa02 / Fi02 > 300 mmHg

Measure: Blood Gas Analysis at Day 2

Time: At 2 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 2

Time: At 2 days after RT

Measure: Oxygen Therapy Status at Day 5

Time: At 5 after RT

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5

Time: At 5 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 5

Time: At 5 days after RT

Measure: Oxygen Therapy Status at Day 7

Time: At 7 after RT

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7

Time: At 7 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 7

Time: At 7 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)

Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7

Time: At 7 days after RT

Description: Recovery time after RT administration until hospital discharge or death (<48h; 2-7 days; >7 days; clinical worsening or death)

Measure: Recovery time

Time: From RT administration until hospital discharge or death

Description: COVID-19 negativization test

Measure: COVID-19 status

Time: At 7 days after RT

Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1

Time: At 1 month after RT

Description: Toxicity was assessed and rated according to the NIH Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and RTOG scales.

Measure: Acute Toxicity

Time: 1-3 months after RT

30 Therapies to Prevent Progression of COVID-19, Including Hydroxychloroquine, Azithromycin, Zinc, Vitamin D, Vitamin B12 With or Without Vitamin C, a Multi-centre, International, Randomized Trial: The International ALLIANCE Study

COVID-19 is a global pandemic. So far encouraging results have been shown in different parts of the world with the utilisation of hydroxycloroquine, zinc, and azithromycin, and early studies into some of these, plus some with Vitamin C, have also proven beneficial. Vitamin D levels have also been shown to be an important indicator to the severity of symptoms in COVID-19 patients.

NCT04395768 COVID19 Dietary Supplement: Vitamin C Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Zinc Citrate Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin B12

MeSH:Disease Progression

Primary Outcomes

Description: Composite measure: Change in severity and duration of symptoms

Measure: Symptoms

Time: once daily for 15 days since enrollment/baseline at admission to hospital

Description: total number of days in hospital since admission

Measure: Length of hospital stay

Time: at 15 and 45 days since admission/ enrolment

Description: need for invasive mechanical ventilation or mortality within 15 days from enrolment

Measure: invasive mechanical ventilation or mortality

Time: any time within 15 days from enrolment

Secondary Outcomes

Description: Death

Measure: Mortality

Time: 15 and 45 days since enrolment

Description: need for and number of days of invasive mechanical ventilation, in case of no need for mechanical ventilation: days=0

Measure: mechanical ventilation

Time: at 15 and 45 days since enrolment

Description: need for and number of days for humidified high-flow oxygen

Measure: oxygen

Time: 15 and 45 days since enrolment

Description: admission to ICU (intensive care unit)

Measure: ICU

Time: 15 and 45 days since enrolment

Description: days in hospital

Measure: days in hospital

Time: 15 and 45 days since enrolment

Description: days in ICU

Measure: days in ICU

Time: 15 and 45 days since enrolment

Description: need for and days of renal replacement therapy

Measure: renal replacement therapy

Time: 15 and 45 days since enrolment

Description: need for and days of Extracorporeal support

Measure: Extracorporeal support

Time: 15 and 45 days since enrolment

31 A Pilot Study for COVID-19 Outpatient Treatment With the Combination of Ivermectin-azithromycin-cholecalciferol

As the world faces COVID-19, the search for effective treatments against the disease and its complications has turned its gaze to drugs that are classically used in other infectious diseases. Some drugs are being examined for the recent evidence on its effects on viral replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase serum concentration of 25-hydroxyvitamin D.

NCT04399746 COVID Drug: Ivermectin Drug: Azithromycin Drug: Cholecalciferol

Primary Outcomes

Description: Test for virus at day 1 and 14 from beginning of trial drug started

Measure: Viral clearance

Time: 14 days

Secondary Outcomes

Description: The duration of symptoms in days

Measure: Symptoms duration

Time: 14 days

Description: oxygen saturation

Measure: SpO2

Time: 14 days

Description: Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio

Measure: SpO2/FiO2

Time: 14 days

32 Anti-Androgen Treatment for COVID-19

This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection

NCT04446429 COVID-19 SARS-CoV2 Androgenetic Alopecia Prostate Cancer Benign Prostatic Hyperplasia SARS (Severe Acute Respiratory Syndrome) Drug: Dutasteride Drug: Ivermectin Drug: Azithromycin Drug: Proxalutamide

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Prostatic Hyperplasia Alopecia Hyperplasia

HPO:Alopecia Alopecia of scalp Benign prostatic hyperplasia Frontal balding

Primary Outcomes

Description: Percentage of subjects hospitalized due to COVID-19

Measure: COVID-19 hospitalization

Time: 30 days

Description: COVID Ordinal Scale defined as: Death Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)

Measure: COVID-19 Ordinal Outcomes Scale

Time: 30 days

Secondary Outcomes

Description: Symptoms severity of COVID-19 using Brescia-COVID Respiratory Severity Scale (BCRSS)/Algorithm

Measure: Symptoms severity of COVID-19

Time: 30 days

33 Application of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy for Critically-Ill COVID-19 Patients

Novel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%. The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection. Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding. Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.

NCT04457609 COVID Pulmonary Infection Sars-CoV2 Drug: Oseltamivir Drug: Azithromycin Biological: Umbilical Cord Mesenchymal Stem Cells

MeSH:Critical Illness

Primary Outcomes

Description: Assessing whether the patients still have dyspnea, one of cardinal symptoms of Covid-19, assessed from the respiratory rate

Measure: Clinical improvement: Presence of dyspnea

Time: 15 days

Description: Assessing whether the patients still have productive cough, one of cardinal symptoms of Covid-19, assessed from lung auscultation

Measure: Clinical improvement: presence of sputum

Time: 15 days

Description: Assessing the presence of fever from measurement of body temperature checking, assessed on daily basis

Measure: Clinical improvement: fever

Time: 15 days

Description: Assessing whether the patients still require ventilation, one of cardinal symptoms of ARDS in Covid-19, assessed from patients' ability during ventilation weaning phase

Measure: Clinical improvement: ventilation status

Time: 15 days

Description: Assessing the patients' blood pressure on daily basis

Measure: Clinical improvement: blood pressure

Time: 15 days

Description: Assessing the patients' heart rate on daily basis

Measure: Clinical improvement: heart rate

Time: 15 days

Description: Assessing the patients' respiratory rate on daily basis

Measure: Clinical improvement: respiratory rate

Time: 15 days

Description: Assessing the patients' oxygen saturation on daily basis

Measure: Clinical improvement: oxygen saturation

Time: 15 days

Secondary Outcomes

Description: Assessing the changes in total leukocyte upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from leukocyte level

Time: 15 days

Description: Assessing the changes in lymphocytes level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from lymphocytes level

Time: 15 days

Description: Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood pH

Time: 15 days

Description: Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood level of CO2

Time: 15 days

Description: Assessing the changes in blood base excess level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood base excess level

Time: 15 days

Description: Assessing the changes in blood oxygen partial pressure upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood oxygen partial pressure

Time: 15 days

Description: Assessing the changes in blood level of HCO3 upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood level of HCO3

Time: 15 days

Description: Assessing the changes in blood level of O2 saturation upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood level of O2 saturation

Time: 15 days

Description: Assessing the changes in level of CRP, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from level of CRP

Time: 15 days

Description: Assessing the changes in laboratory parameter, consist of SGOT/SGPT (AST/ALT) level, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from level of SGOT/SGPT (AST/ALT)

Time: 15 days

Description: Assessing the changes in laboratory parameter, consist of ureum/creatinine level, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from the level of ureum/creatinine level

Time: 15 days

Description: Assessing the changes in laboratory parameter, consist of eGFR, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from the level of eGFR

Time: 15 days

Description: Assessing the changes in level of sodium, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from the level of sodium

Time: 15 days

Description: Assessing the changes in level of potassium, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from the level of potassium

Time: 15 days

Description: Assessing the changes in level of chloride, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from the level of chloride

Time: 15 days

Description: Assessing the changes in procalcitonin level to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: Changes in procalcitonin level

Time: 15 days

Description: Assessing the changes in albumin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from albumin level

Time: 15 days

Description: Assessing the changes in total bilirubin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from total bilirubin level

Time: 15 days

Description: Assessing the changes in D-Dimer to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: Changes in D-Dimer level

Time: 15 days

Description: Assessing the changes in fibrinogen to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: Changes in fibrinogen level

Time: 15 days

Description: Assessing the changes in troponin level to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: Cardiac changes from troponin level

Time: 15 days

Description: Assessing the changes in NT proBNP to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: Cardiac changes from NT proBNP level

Time: 15 days

Description: Assessing the changes in leukemia inhibiting factor (LIF) to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in Leukemia Inhibiting Factor

Time: 7 days

Description: Assessing the changes in level of IL-6 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of IL-6

Time: 7 days

Description: Assessing the changes in level of IL-10 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of IL-10

Time: 7 days

Description: Assessing the changes in vascular endothelial growth factor (VEGF) to assess the effect of growth factors in the MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of vascular endothelial growth factor (VEGF)

Time: 7 days

Description: Assessing the changes in level of ferritin to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of ferritin

Time: 7 days

Description: Assessing the changes in level of CXCR3 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of CXCR3

Time: 7 days

Description: Assessing the changes in level of CD4 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of CD4

Time: 7 days

Description: Assessing the changes in level of CD8 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of CD8

Time: 7 days

Description: Assessing the changes in CD56 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of CD56

Time: 7 days

Description: Assessing the changes in radiology examination (Chest X-Ray/CT Scan) for any increased in lung infiltration or ground glass opacity, assessed prior to implantation and once every 3 days post-implantation

Measure: Radiologic Improvement from Chest X-Ray/CT Scan

Time: 15 days

34 Open Label Non-comparative Trial of the Combination of Hydroxychloroquine and Azithromycin in the Treatment of Hospitalized Patients With Moderate or Severe COVID-19 Infection

This research is designed as an open-label,non-comparative prospective trial.

NCT04458948 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Description: To measure the duration of viral shedding in respiratory secretions of patients with moderate or severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin. Measured via negative PCR test from nasopharyngeal swabs or oropharyngeal swabs in nonventilator dependent patient or tracheal secretions in ventilator dependent patient on days 3, 6, and 14.

Measure: Duration of viral shedding

Time: 1 month

Description: Evaluate the case fatality rate in hospitalized patients with moderate and severe COVID-19 infection.

Measure: Evaluation of Fatality Rate

Time: 6 months

Description: Evaluation of clinical response in hospitalized patients with moderate and severe COVID-19 infection.

Measure: Evaluation of Clinical Response

Time: 6 months

Description: Evaluate the length of hospital stay in hospitalized patients with moderate and severe COVID-19 infection.

Measure: Evaluation of Length of Hospital Stay

Time: 6 months

35 A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection

This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.

NCT04459702 COVID COVID-19 Corona Virus Infection Coronavirus Infection Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere Coronavirus-19 SARS-CoV 2 SARS Pneumonia Drug: hydroxychloroquine Drug: Azithromycin Drug: Ritonavir Drug: Lopinavir

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores

Time: 6 months

Description: Time to non-infectivity as measured by PCR testing

Measure: Efficacy of Treatment by Time to Non-Infectivity

Time: 10 days

Secondary Outcomes

Description: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores

Time: 6 months

Measure: Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.

Time: 6 months

Description: Changes in blood parameters measured in a Complete Blood Count (CBC).

Measure: Safety of Dual Therapy as Measured by Complete Blood Count

Time: 6 months

Description: Changes in blood parameters measured in a Complete Metabolic Panel.

Measure: Safety of Quadruple Therapy as Measured by Complete Blood Count

Time: 6 months

Description: Changes in serum albumin levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel -Albumin

Time: 6 months

Description: Changes in serum albumin levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin

Time: 6 months

Description: Changes in serum albumin/globulin ratio

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio

Time: 6 months

Description: Changes in serum albumin/globulin ratio

Measure: Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio

Time: 6 months

Description: Changes in serum alkaline phosphatase levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase

Time: 6 months

Description: Changes in serum alkaline phosphatase levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase

Time: 6 months

Description: Changes in serum AST levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - AST

Time: 6 months

Description: Changes in serum AST levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - AST

Time: 6 months

Description: Changes in serum ALT levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT

Time: 6 months

Description: Changes in serum ALT levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel ALT

Time: 6 months

Description: Changes in serum BUN/Creatinine Ratio

Measure: Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio

Time: 6 months

Description: Changes in serum BUN/Creatinine Ratio

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio

Time: 6 months

Description: Changes in serum Blood Urea Nitrogen levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN

Time: 6 months

Description: Changes in serum Blood Urea Nitrogen levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - BUN

Time: 6 months

Description: Changes in serum calcium levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Calcium

Time: 6 months

Description: Changes in serum calcium levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium

Time: 6 months

Description: Changes in serum carbon dioxide levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide

Time: 6 months

Description: Changes in serum carbon dioxide levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide

Time: 6 months

Description: Changes in serum chloride levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Chloride

Time: 6 months

Description: Changes in serum chloride levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride

Time: 6 months

Description: Changes in serum creatinine levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine

Time: 6 months

Description: Changes in serum creatinine levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine

Time: 6 months

Description: Changes in serum globulin levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Globulin

Time: 6 months

Description: Changes in serum globulin levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin

Time: 6 months

Description: Changes in blood glucose levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose

Time: 6 months

Description: Changes in blood glucose levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Glucose

Time: 6 months

Description: Changes in blood potassium levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Potassium

Time: 6 months

Description: Changes in blood potassium levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium

Time: 6 months

Description: Changes in serum total bilirubin levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin

Time: 6 months

Description: Changes in serum total bilirubin levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin

Time: 6 months

Description: Changes in serum total protein levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein

Time: 6 months

Description: Changes in serum total protein levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein

Time: 6 months

Description: Presence or absence of treatment related serious adverse events Grade III or higher

Measure: Safety of Dual Therapy as Measured by Treatment Related SAE

Time: 6 months

Description: Presence or absence of treatment related serious adverse events Grade III or higher

Measure: Safety of Quadruple Therapy as Measured by Treatment Related SAE

Time: 6 months

Related HPO nodes (Using clinical trials)

HP:0001596: Alopecia

Genes 287

PLEC APCDD1 KLHL24 EDARADD MPLKIP RAG1 FGFR1 ARHGAP31 NOP10 TERT KRT81 LSS TP63 LAMA3 PNPLA6 ERCC5 PADI3 ALMS1 HR KRAS SLC39A4 MBTPS2 FLI1 PORCN LAMA3 RAG2 PKP1 GTF2H5 WRAP53 SLC29A3 DMXL2 FZD2 HLCS GNA11 DSG4 LMNA ATR HFE ARHGAP31 KRT81 UROS TTC7A NSDHL XPC RHOA DSP SMARCA2 AEBP1 MBTPS2 LSS GJB6 HRAS ROR2 LMNA ABCD1 EPS8L3 RIPK4 GTF2E2 GJA1 RNF113A RPL21 ZNF341 KDM5C NXN MGP PLEC VDR CD28 LIG4 SNRPE EDNRA DOCK6 IL7R GJB2 FTL COL7A1 IKBKG CLDN1 HTRA1 CERS3 TINF2 COL3A1 DSG4 NRAS ALOXE3 SOX18 NRAS MBTPS2 MBTPS2 DLL4 NFKB2 NFKB2 IKBKG RIPK4 SLC39A4 FGFR1 KRT14 PEX7 ADA KRAS AHSG COL17A1 PTPN22 LAMB3 UROD RBPJ GJB6 ABHD5 RTEL1 HLA-DRA GJB6 ABHD5 KRT86 OFD1 CTLA4 HFE MMP1 SPP1 DCAF17 EXOSC2 DCAF17 DSP UBR1 TINF2 EBP DCLRE1C TP63 MBTPS2 FAM111B KRT85 PORCN ALOXE3 TGM1 SLITRK1 HR CSTB HLCS ACVR1 SASH1 KRT16 COL17A1 TP63 XPA ERCC3 LIPH RAG2 ZMPSTE24 ALOX12B HFE OFD1 LAMC2 DSP DVL1 LMNA FOXN1 LMNA KRT83 RNU4ATAC PNPLA1 ANTXR1 NPM1 STAT4 KRT86 AIRE AIRE RMRP TP63 PRKACA UQCRFS1 HR FOXN1 ERCC3 HRAS ACVR1 VDR JUP TRPV3 NOTCH1 DMPK DKC1 BTD RBM28 SNRPE LAMC2 BCS1L DVL3 BTNL2 NECTIN1 GJB4 EBP COL7A1 TGM1 GJB3 MMP1 ERCC2 LMNA GJB2 ECM1 RBM28 CHD7 IRAK1 ABCA12 TERC NECTIN4 CD28 CASR IL7R KRT17 TERT TARS1 IL2RG ALMS1 BMP2 KRAS NFKB1 COL18A1 DDB2 TINF2 WNT5A TRPV3 ALX4 PARN EOGT FOXP3 KDM5C AHSG WNT10A KDSR RIN2 SOX18 PIK3R1 GJB2 TERC GJA1 ERCC2 DCLRE1C CTLA4 STUB1 AP1B1 ITGB4 IL2RA TGM1 NIPAL4 PERP NHP2 HLA-DRB1 LMNA ALX4 CLDN1 ZMPSTE24 KRT74 EDAR KRT83 BTK USB1 ZMPSTE24 MBTPS2 LAMB3 TGM3 ERCC4 KRT6B ECM1 BTD BCS1L CTC1 LPAR6 MCCC2 ITGB6 KRT6A GJA1 RECQL4 HR EPS8L3 TNFRSF1B COL7A1 DKC1 ANTXR1 WNT10A TP63 RAG1 SLC30A2 ITGB4 COL3A1 TNFRSF1B SOX18 ALOX12B PARN

Protein Mutations 0

SNP 0

Protein Mutations 0

SNP 1

rs2180439

HP:0008711: Benign prostatic hyperplasia

Protein Mutations 0

SNP 0

HP:0002014: Diarrhea

Genes 377

ALAD CCDC47 CBL KCNJ1 TTR RAG1 SCN11A SLC46A1 ELP1 NEUROG3 BLNK CPOX SGSH SLC25A13 MVK IKBKB CD79A MPI POLG CD19 TRNF ATRX SLC39A4 RIPK1 LCT IGHM CLMP CD79B SYNJ1 TTC7A UCHL1 SDHD SAMD9 PTEN ZAP70 RAG2 PKP1 SERPING1 CDKN1B TYMP PIGT TTC37 CYP11B2 SCNN1B ADAM17 PHKB WNT2B NEUROG3 SNCA SAA1 HADH BTK HYOU1 GNS DBH SERPING1 LRBA ND1 ND4 TTC7A RRM2B COG4 ALDOB SCNN1A CD40LG SMARCD2 STX3 ABCB11 CFH ACVRL1 TSHR NCF4 NAXD AKR1D1 PODXL SLC5A1 POLG PALLD HLA-B TRNQ CDKN2A RUNX1 EDN3 RAG1 MPV17 NOD2 CTLA4 F5 SLC7A7 JAK3 TCN2 MEN1 IL21 ICOS MYO5B ITGA2 MRAP RFXAP TTC37 LIG4 HSD3B7 LRRK2 SUGCT MYD88 B2M GINS1 IL7R PALB2 ITGA2B ANTXR2 NAGLU OTULIN KIF1B KCNJ11 IL21R KRAS COX3 SP110 CYP27A1 SMAD4 AGA GP1BB NHLRC2 TNFRSF1A DAXX HGSNAT ABCC8 MLYCD IKZF1 DGAT1 VPS13C PTPRC ZAP70 RAG2 SCN9A TFRC OPLAH GLA SLC39A4 CARMIL2 EGFR ADA ABCB4 RAG1 SLC9A3 PARK7 HTRA2 CYP7B1 TRNS2 SI ITCH AK2 IL2RG DCLRE1C ASXL1 IGHM SERPING1 SPP1 TREH TXNRD2 SEMA3D RFXAP FBP1 ERCC2 SLC46A1 LRRC8A TLK2 SMAD4 CDKN1A DCLRE1C TRNS1 ATP8B1 SLC25A13 ACAT1 PMM2 EFL1 GDNF C5 ADA SLC12A3 MVK ICOS CDKN2C TRNH NAGS DDC CD247 GFI1 BMPR1A ACSF3 STAR RFXANK GALT ITGB4 FOXP3 CD79A PINK1 ETHE1 NLRC4 CD3D PLEC PIK3R1 ENG ELANE WIPF1 IL2RG TTR CPT1A SRP54 LIG4 BMPR1A TMPRSS15 HNF1A SAR1B CD247 GUCY2C STAT1 PPP2R5D MVK EDNRB ALG3 TET2 KIF23 RAG2 WAS SLC10A2 TGFB1 CD3E SPINT2 MC2R EPCAM DNASE1L3 RNF113A CLCNKB ITGA6 IFNGR1 COG6 CIITA STAT4 WAS AIRE RNF168 GP1BA RMRP SKIV2L BMPR1A G6PC SKIV2L RFX5 TNFRSF13C MGME1 TSHR DNMT3B DMPK PPP2R5D UCP2 BRCA1 APC NNT HNF4A TP53 TKFC ACSF3 HEXB COX1 ENG NSUN2 JAK3 CFHR1 TRNW IDS TYMP ND5 ANTXR2 CD79B ACADM CHD7 MYO5B ATP7A IGLL1 IRAK1 PCSK1 TNFRSF13B HPS1 PRKN HMGCS2 ND6 TCIRG1 IL7R SRSF2 CR2 CYP27A1 IL2RG BRCA2 IL2RB IL10RA PLVAP HMGCL BMPR1A RET GREM1 RAG2 ITGB3 TERT MEFV ECE1 AVP FOXP3 GATA6 SMAD4 NR3C2 HMBS NOD2 RECQL4 BTK RFXANK SEMA3C DES AP1S1 CDKN1B SLC12A1 IL6ST RFX6 RET RECQL4 TCF3 DCLRE1C USP7 MCM6 PIK3R1 CIITA ARX CR2 COG4 LIPA COX2 BLM NRTN SLC26A3 IGKC IL2RA LCK ETHE1 ACTG2 CD3D SLC7A7 NBN MEN1 CASP8 ADA IL7R SCNN1G MGME1 CD109 MAOA BTK BLNK CD55 IL6 IDUA SAR1B NBN SMAD4 ALG8 BTD RFX5 SLC19A2 SON CDKN2B TRNL1 STAT1 POLA1 RAG1 CFHR3 LIPA ASAH1 DNAJC6

Protein Mutations 1

R192G

SNP 0

HP:0002292: Frontal balding

Genes 4

NR3C1 DMPK WNT4 CNBP

Protein Mutations 0

SNP 0

HP:0002090: Pneumonia

Genes 220

KMT2D OSTM1 GBA RSPH1 DOCK8 NKX2-1 RNU4ATAC SPAG1 RAG1 MCIDAS AFF4 TNFRSF13C DNAH1 NOTCH3 CD19 ALMS1 NADK2 UNC119 SFTPC FOXN1 CD79B CFAP221 CD81 SAMD9 MED25 ZAP70 RAG2 IGLL1 DNAAF1 RPGR STK36 LTBP3 PLOD1 DNAH9 BTK TERT COL11A2 OFD1 TNFRSF11A LRBA RSPH4A CD19 NME8 SMARCD2 GAS8 CFTR TNFRSF13B CCDC65 CFAP298 COL11A2 RAG1 ORC6 P4HTM MAN2B1 CFAP300 JAK3 CACNA1C ICOS SETBP1 TNFRSF13C SPEF2 LIG4 NIPBL STAT3 ZMYND10 IL7R MAN2B1 HLA-DQA1 IL21R SELENON SP110 ACADVL CCDC39 ARMC4 NSMCE3 NFIX DNAI2 ACP5 PTPRC ZAP70 KIAA0586 FCGR2A NFKB2 NEK10 MTHFD1 EGFR RYR1 ADA DNAI1 TGFB1 DNAAF6 IL2RG KCNJ6 DCLRE1C CCDC103 IGHM GNPTAB DNAAF4 PNP CFB DCLRE1C TAF1 CARD11 USB1 ADA ICOS FMO3 IL2RG HLA-DQB1 GFI1 SFTPA2 ICOS CD3D FOXJ1 CRLF1 ELANE IL2RG SRP54 NFKB1 PANK2 GAS2L2 CD247 IRF8 GAS8 RAG2 CCDC151 WAS ZBTB24 CD3E DNAL1 EXTL3 SLC35A1 NCF1 TK2 MS4A1 IFNGR1 RNF168 RMRP RSPH9 NHLRC1 MUC5B TNFRSF13C DNAH5 DNMT3B RNF125 EPM2A TTC12 JAK3 LEP RAC1 CYBA PGM3 NOS1 DDR2 AFF4 TBC1D24 CHD7 TNFRSF13B OFD1 DNAI1 RANBP2 TCIRG1 DNAJB13 CR2 CCDC40 IL2RG NCF2 RAG2 SLC25A24 SGCG WDR19 FOXP3 RNU4ATAC ACTA1 UBB CFAP410 BTK TTC25 CARD11 DNAAF2 CXCR4 MASP2 DRC1 TBCD DCLRE1C CYBB RSPH3 LRRC6 PIGN TNFSF12 DNAAF5 CCNO CSPP1 CR2 SLC35C1 HYDIN TIMM8A NBN NFKB2 CCDC114 CASP8 ADA IL7R CCDC114 TNFSF12 BTK LRRC56 PEPD BLNK CD55 GRHL3 NBN PRKCD KPTN PMM2 DNAAF3 KDM6A POLA1 RAG1 DNAH11

Protein Mutations 6

A2063G G551D K55R L460D R287Q S1009A

CovidResearchTrials by Shray Alag

Covid 19 Research using Clinical Trials (Home Page)

AzithromycinWiki

Developed by Shray Alag

Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (85)

Correlated MeSH Terms (23)

Correlated HPO Terms (4)

Clinical Trials

1 Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

NCT00043264 Multiple Sclerosis Drug: Rifampin Drug: Azithromycin

MeSH:Pneumonia Multiple Sclerosis Sclerosis

HPO:Pneumonia

2 Proactive Prophylaxis With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19

NCT04322396 Virus Diseases Infection Viral Corona Virus Infection Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo oral tablet Drug: Placebo oral tablet

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Severe Acute Respiratory Syndrome Virus Diseases

Primary Outcomes

Secondary Outcomes

3 Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial

NCT04329832 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Secondary Outcomes

4 Pilot, Randomized, Multicenter, Open-label Clinical Trial of Combined Use of Hydroxychloroquine, Azithromycin, and Tocilizumab for the Treatment of SARS-CoV-2 Infection (COVID-19)

NCT04332094 COVID-19 Drug: Tocilizumab Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

5 Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19

NCT04332107 COVID-19 SARS-CoV-2 Drug: Azithromycin Drug: Placebos

Primary Outcomes

Secondary Outcomes

6 Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial

NCT04334382 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Secondary Outcomes

7 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

NCT04334512 COVID-19 Corona Virus Infection Coronavirus-19 Sars-CoV2 Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

8 Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

NCT04335552 SARS-CoV-2 Other: Standard of care Drug: Hydroxychloroquine Drug: Azithromycin

MeSH:Infection

Primary Outcomes

Secondary Outcomes

9 Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment

NCT04338698 COVID 19 Drug: Hydroxychloroquine Drug: Oseltamivir Drug: Azithromycin

Primary Outcomes

10 Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care Due to Coronavirus Disease 2019 (COVID-19)- Randomised Controlled Trial

NCT04339816 COVID-19 Respiratory Failure Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo

MeSH:Respiratory Insufficiency

Primary Outcomes

Secondary Outcomes

11 COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients

NCT04341207 Cancer Cancer & Cancer & COVID 19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

12 WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection

NCT04341727 Coronavirus Infection Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Chloroquine Sulfate

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Secondary Outcomes

13 Efficacy of Sarilumab + Azithromycin + Hydroxychloroquine, and Sarilumab Alone, for Adult Patients Hospitalized With Moderate to Severe COVID-19: a Multicenter Open-label 1:1 Randomized Controlled Trial

NCT04341870 COVID19 SARS-CoV-2 Infection Drug: Sarilumab Drug: Azithromycin Drug: Hydroxychloroquine

Primary Outcomes

Secondary Outcomes

14 Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial

NCT04344444 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

15 Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

NCT04349592 Covid19 Drug: Hydroxychloroquine Drug: Azithromycin Other: Placebo Tablet Other: Placebo capsules

Primary Outcomes

Secondary Outcomes

16 Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial

NCT04354428 COVID-19 SARS-CoV-2 Drug: Ascorbic Acid Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Folic Acid

Primary Outcomes

Secondary Outcomes

17 Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia: A Pragmatic Randomized Controlled Trial

NCT04359095 COVID-19 Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Pill Drug: Azithromycin Other: Standard treatment

Primary Outcomes

Secondary Outcomes

Other Outcomes

18 Efficacy and Safety of Azithromycin Compared to the Base Therapeutic Regiment of Hydroxychloroquine in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial

NCT04359316 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin